https://www.avient.com/news/pharmapack-2025-feature-polymer-colorants-and-additives-avient-enhance-performance-and-sustainability
The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”
https://www.avient.com/news/avient-and-plastic-bank-reuse-ocean-bound-plastic-luxury-caps-and-closures
¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.
https://www.avient.com/news/avient-features-specialty-healthcare-material-solutions-services-mdm-west-2022
Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.
https://www.avient.com/news/non-pfas-flame-retardant-formulations-expand-avient-s-compl-t-long-fiber-polyketone-portfolio
These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/sites/default/files/2021-01/avient-colorants-sweden-ab-certificate-of-registration.pdf
e-Certificate of registration
Swedish Companies Registration Office
LIMITED COMPANY
D1a- 6064988
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
556393-1020
1990-04-10
2020-11-30 14:53
2020-11-30
1 (2)
Registration number: 556393-1020
Business name: Avient Colorants Sweden AB
Address:
Box 9053
200 39 MALMÖ
Registered office: Malmö
Note:
The company is registered as a private limited company.
THE COMPANY WAS FORMED
1990-03-29
SHARE CAPITAL
Share capital...: SEK 3,200,000
Min.............: SEK 3,000,000
Max.............: SEK 12,000,000
Number of shares: 32,000
Min.............: 30,000
Max.............: 120,000
BOARD MEMBER, MANAGING DIRECTOR
660613-3954 Nilsson, Bo Patrik Joakim, Hovslagaregatan 13, 271 57 YSTAD
BOARD MEMBER, CHAIR OF THE BOARD
640503 Merklein, Norbert, Fichtenstrasse 20,
61476 KRONBERG IM TAUNUS, TYSKLAND
BOARD MEMBERS
750618-4089 Norén, Jenny Eva Kristina, Fårabäcksvägen 68, 212 91 MALMÖ
610322 Smeds, Jan-Håkan, Chämiweg 23, NEFTENBACH, TYSKLAND
AUDITORS
556029-6740 Öhrlings PricewaterhouseCoopers AB, Box 4009, 203 11 MALMÖ
Represented by: 710921-4689
PRINCIPALLY RESPONSIBLE AUDITOR
710921-4689 Olsson, Karin Maria, c/o PwC, 405 32 GÖTEBORG
SIGNATORY POWER
e-Certificate of registration
Swedish Companies Registration Office
LIMITED COMPANY
D1a- 6064988
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
556393-1020
1990-04-10
2020-11-30 14:53
2020-11-30
2 (2)
The board of directors is entitled to sign.
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
H Y P O D E R M I C N E E D L E
M A N U FAC T U R E R
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-01/avient-puerto-rico-llc-certificate-of-amendment.pdf
Roman, Secretary of State of the Government of Puerto Rico,
CERTIFY: That on July 13, 2020, at 08:50 AM, "POLYONE PUERTO RICO,
LLC", registry number 365432, performed the following transaction:
Name Change
Previous Actual
POLYONE PUERTO RICO, LLC AVIENT PUERTO RICO, LLC
CERTIFICATE OF AMENDMENT
Government of Puerto Rico
IN WITNESS WHEREOF, the undersigned by virtue
of the authority vested by law, hereby issues this
certificate and affixes the Great Seal of the
Government of Puerto Rico, in the City of San Juan,
Puerto Rico, today, July 13, 2020.
https://www.avient.com/sites/default/files/2022-08/Avient CDP_Climate_Change_Questionnaire_2022.pdf
In addition, Avient has externally
certified EHS&S management systems, including ISO 9001 worldwide.
Additionally, 52% of our
facilities are certified to ISO 14001, 56% to Responsible Care 14001 and ISO 45001, and 10%
of our high energy sites are certified to ISO 50001.
Additionally, 52% of our
facilities are certified to ISO 14001, 56% to Responsible Care 14001 and ISO 45001, and 10%
of our high energy sites are certified to ISO 50001.